Medical Clinical Trials- Would you?

[Scott Shepherd]

Last week I had a family member in the hospital with a serious issue. While in the emergency room, one of the doctors made a call and said "We might have a candidate for you", then hung up the phone. They later explained there was a clinical trial going on and it might be something to consider doing.

About 30 minutes later, this young lady comes into the emergency room and says she's the one with the clinical trial. She explains it's a 7 year study and they are 1 year into the study. You will never know your own results, it's all part of the long term study that lasts 6 months.

She explains that 50% of the people will be given a placebo and 50% will get the actual medicine.

I asked "What if this person actually NEEDS the medicine to keep them from getting worse?".

She tells me that if the person being treated has another "medical event", then they can get the treatment they need to save their life and it will automatically opt them out of the study.

I asked "What if they have a "medical event" where they aren't close to treatment and they die, all because they should have been taking the medicine, but were actually being fed a placebo?".

She said "That's possible".

She hands over a packet of paper on it and says she'll see us later for the decision.

I sat down and read the paper work, as much as I needed to, and sure enough, there is a clause in the paper work that states that by entering the study, you could possibly be taking the risk of not getting medicine that you actually need to save your life.

So, we opted not to participate in the study. When the lady came to the room to get the answer and we told her "no thanks", she asked why and couldn't seem to understand our concerns. She said she understood, but kept trying to explain her way out of it and our way back into it.

Our decision was made, we wouldn't allow someone in our family to possibly be deprived of medicine they actually need to keep them alive and not have another serious "medical event".

I guess I never thought that they were doing trials on that level, of actually not giving people medicine they need.

What would your decision be?

[Jamie Buxton]

Usually a medical trial is testing a med that might or might not work. That's why they're conducting a trial with it. Even when a patient gets the drug that they're testing, the drug might not do any good.

[Greg Peterson]

It's a moral dilemma. Advance the state of medicine for the benefit of future generations or receive the benefits from the risks taken by previous generations.

I can think of circumstances where I would participate in a trial program. I can also think of circumstances where I would be very unlikely to participate.

For instance, a terminal condition could very possibly give the trial a go.

[Abi Parris]

If I had a terminal illness without any treatment options, I would participate in a a study whether or not it would be a blind or double-blind study. Also, there are "phases" (I, II or III) of clinical trials I would participate in as long as by entering, the condition would/could not worsen to the point of limiting future treatment options.

[Steve DiMasi]

My understanding of clinical trials is that the medicine is ONLY available to those in the test. So, even in the case of another medical event, if they are not part of the study that medicine would not be available to them at all.

The part about being given the real thing in another medical event is a good thing, but it would mess up the study to allow that person to remain in the study afterward since they would then know that they were given the drug and not a placebo.

If I were in your shoes, I'd ask for that clarification and if it is indeed only available to study participants under any circumstances, you may want to reconsider.

[Scott Shepherd]

My understanding of clinical trials is that the medicine is ONLY available to those in the test.

Nope, it's a drug you see commercials for every day on tv. It's been out for years. It was one of the top 3 selling drugs in the world several years in a row. That was my question. Why don't we just take the drug and forget about your study, then we're covered, as far as the medicine helping the person in question.

It's like saying if you have a headache, I can give you an aspirin or a sugar pill, which one do you want? If you give me the choice, I'll take the aspirin. If I'm in a study, I might get aspirin, I might get sugar. Now make that a life threatening condition. I know which one I'll take.

[Ken Fitzgerald]

Scott,

This is a very personal decision and I don't think there is a right answer or an wrong answer. I believe only the person who is involved should make the decision and personally, I couldn't fault them for their decision. In the case of a child or an elderly person unable to make the decision, the responsibility should pass to the parents or responsibile person.

Tough decision.

Nearly 19 years ago, my wife was diagnosed with a rare but deadly form of cancer. She is not a "detail" person while I am. After going to the medical library and reading everything there about her condition, I just made sure she understood what her options were and the possible outcomes of each option. I did it without going into details and I made sure nobody influenced her decision. It was too important and she had to live or DIE with the results. She made her decision ( I happened to agree with it) and she's still with me today.

Decisions of this importance and type are personal, important and IMHO there is no right decision....there is no wrong decision.....there is just a very personal decision about which nobody has a right to 2nd guess or pass judgement.

[Scott Shepherd]

I agree, it's a personal decision, and we made ours. I was just curious what others would do.

Me, personally, if a drug keeps me from having a serious medical event, I want that, not the possibility of a placebo.

I agree with others, if I had a terminal illness, I'd probably be very open to participating.

[Steve DiMasi]

Wow. That changes everything. Given that it's so readily available, I totally agree with your decision and would have done the same thing. Terminal would be different.

[Jim Koepke]

I guess I never thought that they were doing trials on that level, of actually not giving people medicine they need.

This is a standard part of drug testing to eliminate the "placebo effect."

Some drugs come back testing as even less effective than sugar pills. Hard to imagine, but it happens.

It does seem strange that it was being done with a drug that is already on the market. The only way that makes sense to me is if the drug is about to go "off patent" and it has been reformulated to extend the patent.

If that were the case, I would have also refused the test.

One interesting story I heard involving a drug test was for a medicine to control blood pressure. It wasn't as effective as other drugs for lowering blood pressure and some side effects were reported. At the end of the test when the researchers asked for a return of all unused medications, a standard procedure, many of the men asked if they could keep the pills, not a usual occurrence. Apparently, there was an unreported side effect, and that is supposedly how Viagra was discovered.

jtk

[Don Jarvie]

Most likely their going for a new indication for another disease or condition to treat. A placebo trial is the best way to see if a drug works since the other half only takes sugar pills. As for the "Placebo Effect", this actually gets factored out when the design the trial. They have to make sure there are enough volunteers in the study to eliminate any placebo effect so they know that the drug is working and not someone says they feel better when they take the placebo.

This is why trials are volunteery and no one is forced to participate. There are risks and benefits to all clinical trials and like it has been said you need to make the best decision for you and your family.

[David Weaver]

I'm sure that lady well understood why you said no.

I'm sure she also knows well that if she just agrees with you right away, she has no chance of you changing your mind. If you're a pushover and she pretends like she can't see why you'd make a decision, then she at least has a chance of getting people who were on the fence or who question themselves.

That's why it's always important to make a firm decision when you clearly understand the situation, because you never know what someone else's motives are.

I'll bet she'd have said no if it was one of her family members.

[Dan Hintz]

Nope, it's a drug you see commercials for every day on tv.
Something seems amiss here... we don't have all of the info you do, but they don't run placebo-based, blind trials with drugs that are currently on the market. Doing so would be considered withholding medical care. The reformulated drug is one possibility, but generally they're looking for side-effects from a known working drug, so placebo patients aren't usually used.

Assuming it's a drug not currently on the market, the only way I would say 'no' is if it prevented me from taking other drugs that may save my life (then I would have to weigh the risks). Otherwise, there's no reason not to get into the study... the drug may or may not work, but it's only to your benefit as it's a drug you would normally not have access to.

[Scott Shepherd]

Nope Dan, it's nothing secret or new. It's a brand name, currently used drug. Your conclusion was exactly the same as mine. It actually stated in the paper work that it's possible for you to not be getting the medicine you need in the actual document.

I fully understand what a placebo is and it's reasoning, I just don't understand someone coming into the ER with a serious medical event and you asking them to take a 50/50 shot at whether or not they'd be getting the medicine they need, or if you'd take a 100% shot and just give me the medicine I need.

The trial was to see if people taking the medicine would have another "medical event" versus those taking the placebo. That "medical event" that may or may not happen is serious enough to take someone's life or leave them in such shape they'll never have a normal life again.

The whole thing seemed really odd to me, and in reading the paper work, it seemed even more odd.

[Barry Nelson]

I am a insulin dependent diabetic being treated by a leading Professor here in Wollongong,I have been on two or three clinical trials prior to ascending to insulin, most of them I thought were pretty harmless but the last one which was supposed to be a weight reducing drug as well as a diabetic one has left me with nausea every time I eat,not a great side effect,as the nausea is only very mild ,it was supposed to be a two year trial, but I dropped off after twelve months,side effects were not great,but enough to put me off doing any more trials.Most of the other drugs that I have trialled are now on the market here in Autralia.
I previously worked for Du Pont here in Australia,and know of the crap that drug companies have to go through to get their drugs to market over here, most (if not all)of the drugs are passed by the Therapuetic Goods Administration. Du pont were heavily into the nuclear medicine side of things with what was then New England Nuclear.Used to load up reps car with documentation when they went to Canberrra (which is the equivalent of your Washington)to get approval for some of these drugs used to fill the boot,back seat and most of the time the seat beside the driver.
It ain't easy.

[Chuck Wintle]

Last week I had a family member in the hospital with a serious issue. While in the emergency room, one of the doctors made a call and said "We might have a candidate for you", then hung up the phone. They later explained there was a clinical trial going on and it might be something to consider doing.

About 30 minutes later, this young lady comes into the emergency room and says she's the one with the clinical trial. She explains it's a 7 year study and they are 1 year into the study. You will never know your own results, it's all part of the long term study that lasts 6 months.

She explains that 50% of the people will be given a placebo and 50% will get the actual medicine.

I asked "What if this person actually NEEDS the medicine to keep them from getting worse?".

She tells me that if the person being treated has another "medical event", then they can get the treatment they need to save their life and it will automatically opt them out of the study.

I asked "What if they have a "medical event" where they aren't close to treatment and they die, all because they should have been taking the medicine, but were actually being fed a placebo?".

She said "That's possible".

She hands over a packet of paper on it and says she'll see us later for the decision.

I sat down and read the paper work, as much as I needed to, and sure enough, there is a clause in the paper work that states that by entering the study, you could possibly be taking the risk of not getting medicine that you actually need to save your life.

So, we opted not to participate in the study. When the lady came to the room to get the answer and we told her "no thanks", she asked why and couldn't seem to understand our concerns. She said she understood, but kept trying to explain her way out of it and our way back into it.

Our decision was made, we wouldn't allow someone in our family to possibly be deprived of medicine they actually need to keep them alive and not have another serious "medical event".

I guess I never thought that they were doing trials on that level, of actually not giving people medicine they need.

What would your decision be?

it is not ethical for large companies to play games with the health of any person IMHO...especially one who is need of PROPER treatment for an illness. Google tuskegee study for a case of no ethics shown whatsoever. Big pharma still lack ethics because of the almighty dollar!

[Dan Hintz]

Google tuskegee study for a case of no ethics shown whatsoever.
..........

[Chuck Wintle]

In the Tuskegee case, the study involved actively infecting the members with syphilis under the guise of free healthcare, not handling people who had already contracted it... that's a big no-no.

The Public Health Service, working with the Tuskegee Institute, began the study in 1932. Investigators enrolled in the study a total of 600 impoverished, African-American sharecroppers from Macon County, Alabama, 399 who had previously contracted syphilis before the study began and 201 without the disease. For participating in the study, the men were given free medical care, meals, and free burial insurance. They were never told they had syphilis, nor were they ever treated for it. According to the Centers for Disease Control, the men were told they were being treated for "bad blood," a local term used to describe several illnesses, including syphilis, anemia and fatigue.

[Dan Hintz]

You're right, Chuck, my bad... memory is getting a bit soft in the old age.

[Don Jarvie]

Lets not throw the drug companies completely under the Greyhound. Drugs have saved a lot of lives, prolonged a lot of lives and kept people well and out of the hospital. 60 years ago people died from infections and rarely do today. Drug companies haven't covered themselves in glory in the past decade or so but some do great work.

As for Tuskegee, that was our government at work. Clinical trials have come a long was since then and the hoops you need to jump through with the FDA are much higher.

Just an FYI, you are allowed to take all the time you like to think about participating and always discuss any participation with your own doctor before making a decision. Sometimes you doctor may feel the trial may be worth it depending on your medical condition, etc.

[Scott Shepherd]

Just an FYI, you are allowed to take all the time you like to think about participating and always discuss any participation with your own doctor before making a decision. Sometimes you doctor may feel the trial may be worth it depending on your medical condition, etc.

That wasn't our case. It was about 5:00pm when she came in to talk about it, and she said she needed to know before she left that night, which would be around 7pm.

She came to the room about 20 minutes after our family member was checked into their room.

I don't disagree with trials or drug companies. I'm not anti-either. I just had never been faced with a decision to take medicine that could save your life or take a 50/50 chance of taking the real medicine. That's the part that struck me as odd.

I also didn't realize they were like ambulance chasers in the Emergency Room, trying to sign people up for trials. I always thought it was done outside of the ER, or at least with your own doctors advice on the subject. In the ER, you're no where near your normal doctor, so who are they trying to get to sign up? People that will make a quick decision without understanding the ramifications?

In fact, it's getting almost impossible to GET to your regular doctors these days. Since coming out of the hospital, my family member has been trying for 4 days to MAKE an appointment with their doctor to discuss it. They are talking 2-3 weeks out, which to me, seems a little crazy, but hey, what do I know?

Why wouldn't the testing company just contact the person's doctor and allow them to present the idea at their new visit? No need to hover around the ER, in my opinion.

[Dan Hintz]

That wasn't our case. It was about 5:00pm when she came in to talk about it, and she said she needed to know before she left that night, which would be around 7pm.
Something is wrong with this picture, and I would consider approaching hospital management with this situation. There should never be pressure to enter a trial, and patients should not be treated as if they were buying a car 15 minutes before they shut down the showroom for the night. You should be given at least 24 hours to think it through, and if you're put on the hot seat to make a decision, they are fast approaching lawsuit territory. Fast decisions should only be made to save a patient's life, not to get them into a drug trial before being possibly tainted with other drugs. If you need more time, ask for it... if they say 'no', ask why more time can't be allowed. If it's tainting by other drugs, that's an acceptable reason to not wait. If not, and this is a multi-year study, I can think of no valid reason why.

I also didn't realize they were like ambulance chasers in the Emergency Room, trying to sign people up for trials. I always thought it was done outside of the ER, or at least with your own doctors advice on the subject. In the ER, you're no where near your normal doctor, so who are they trying to get to sign up? People that will make a quick decision without understanding the ramifications?
The doctor should not suggest a particular trial unless they feel you are a good candidate (which was likely here, it sounds like). But yes, they will be waiting in the wings to take whomever fits the studies profile, and I don't have a problem with that (though I'm sure it feels like vultures waiting for their next meal).

[John A. Scott]

Can you add any information that may shed some light on the issue, i.e., what is the drug in question?

[Scott Shepherd]

It was Plavix.

[Stephen Tashiro]

One reason in favoring being in the trial is that the placebo effect is statistically very strong. Sometimes more people get better taking placebos than taking medicines that are known to have some effectiveness.

[John Coloccia]

One reason in favoring being in the trial is that the placebo effect is statistically very strong. Sometimes more people get better taking placebos than taking medicines that are known to have some effectiveness.

Has anyone ever considered that sugar pills are a miracle drug?

[Dan Hintz]

Has anyone ever considered that sugar pills are a miracle drug?
I volunteer to be in that trial... especially if the pills are shaped like Skittle or M&Ms.

[Don Jarvie]

Scott, The only reason for a decision so quick would be for a life threating event and the medication would need to be give within X houses. Based on what you have described that doesn't seem to be the case.

If you really want to make a big deal about it you can contact the Institutional Review Board (IRB) at the hospital. If you received a packet there should be a document called an Informed Consent. Toward the back will be contact information and the person to contact at the IRB will be listed. An IRB is a review board that reviews and approves all protocols being conducted at the hospital. They will weight the risks and benefits of the trial and factor in patient safety. All trials have risk to them but some have more than others and its the IRBs job to weigh this.

One other issue. If you had said yes your family member would not have been enrolled right then and there and given the medication. There is a screening process for all trials that goes over criteria to meet before each patient is enrolled and there would have been a formal sitdown with the study doctor or his/her representative to formally sign the informed consent and answer all questions.

Its too bad the hospital conducted themselves this way to leave a bad taste in your mouth. I work for a drug company so I know how the process works and it seems like they were a bit too pushy.

Hope your family member is doing well.
Don

[Dan Hintz]

Don,

Your response (roughly) mirrors what I sent to Steve in a PM... we weren't there, but the rep definitely appeared too pushy. Unless I'm mistaken, people can be added practically "on the spot", as it were, as long as the residing doctor is aware of all requirements for entry into the trial... this is typically done when getting someone into a trial needs to be decided in a relatively short period of time, but again, long-term trials rarely need this sort of instant access. The whole situation smells...

[Dave Anderson NH]

One issue which hasn't been directly addressed here is financial incentive. In many clinical trials the hospital, a particular physician or group of physicians, or both have a vested interest in signing up the participants and getting a study going quickly. This can be and ofen is a major income producer and the money is paid out to the people or organization running the study. These studies are not done out of the goodness of anyones heart, there is serious money to be made. This is not to say that studies are not useful or needed, but rather the motivation should be in the back of people's minds.

7 years ago my wife had a minor heart attack and was taken by ambulance to a quite good community hospital. Testing and diagnosis determined that she should would likely need to be stented based on the results of an angiogram. The attending cariologist (not her own ) came in and tried to convince us that the angiogram shold be done there and that if the results indicated the need for stenting, she would then be transported 1/2 hour to the Heart Institute at Catholic Medical Center in Manchester NH. The doctor, who practicied at both hospitals, and was a member of the group that would take care of things at CMC if needed, was forced by hospital politics to push for a local angiogram. On my advice, Sue refused. 15 minutes later the female top hospital administrator was in her room very very agressively pushing for the proceedure to be done there. We again refused and the administrator left in an obvious huff. It was all about income for the hospital and any extra risk or pain and suffering by the patient was not something they cared about. If we had allowed them to push, Sue would have ben catheterized in the femoral artery and transported via ambulance with her leg sandbagged while she was in only minor pain as long as the leg didn't get bumped, the ambulance didn't hit bumps in the road, and there were no traffic jams or delays.

The bottom line is that you have to know both the medical side of the story and the know the motivations of the people involved. Follow the money.

[David Weaver]

but rather the motivation should be in the back of people's minds.

Follow the money.

This is exactly what I was talking about when mentioning why the rep may have been pretending not to understand why you wouldn't do a study.

There is no reason to listen to a rep or physician questioning your decision, and I wouldn't be afraid to ask them if they're being paid and what they're being paid. IF they can't tell you what they're being paid, then you have no reason to even discuss any drug trial related stuff with them at all.

Trying to have an objective discussion with someone who is attempting to make additional money from you is fruitless if they are not willing to be open and honest about it.

[Don Jarvie]

Dan, you are right about the rep being too pushy. From what Scott described no on the spot decision was necessary for this type of study.

As for signing up right away. There are very few studies that you would be signed up and given medication within a few hours. Those would be for life threating conditions where minutes make a difference. Most studies have a screening period and some testing may be done before you are enrolled so there is time.

As for the money, drug companies pay the doctor X amount per patient, somewhere between 3000 and 8000 per patient. While it seems a lot there are usually multiple visits to the office and the doctors staff has quite a bit of paper work to do so there are office expenses associated.

One last thing, these trials are monitored by the drug companies very closely and companies will get rid of bad investigators if there are issues. The FDA also monitors trials, not as closely as the company though. Drug trials aren't perfect but this is how new drugs get approved and help people live longer more productive lives.

[Dan Hintz]

Don,

I should have just let you type my PM to Steve... would have saved me some time, and the answer would have been the same ;)

[John A. Scott]

Scott: Is the Plavix study in question the POINT trial?

[Don Jarvie]

From what Scott described that would be it. That explains the hard push since the drug needs to be given within 12 hours. They still could have done a better job explaining the trial.

Anytime you need me Dan send me a note!